Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
Morphosys AG’s rare blood cancer treatment hit its phase III primary endpoint but missed statistical significance on a secondary endpoint, sinking the stock for the day. Top-line data from the study treating JAK inhibitor-naïve patients who have the rare blood cancer myelofibrosis showed the combination of pelabresib, a BET inhibitor, and the JAK inhibitor ruxolitinib produced a statistically significant improvement in spleen volume reduction, which was the primary endpoint.
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.).
Researchers from Universität zu Köln have published data from a study that investigated the pathophysiology of disabling pansclerotic morphea (DPM), and as such, gain better understanding of the much larger range of disorders characterized by poor wound healing and severe, unchecked fibrosis.
By the end of this year, it will become apparent whether Morphosys AG has executed one of the biotechnology industry’s boldest pivots in recent years or has instead blown $1.7 billion of investor cash on a dud. The day of reckoning is coming a little sooner than expected for the Planegg, Germany-based firm, as it has completed recruitment in a phase III trial of pelabresib in first-line myelofibrosis ahead of schedule. Top-line data from the study are now expected before year-end, instead of early 2024.
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
Concert Pharmaceuticals Inc. is on track for an NDA filing for CTP-543 in alopecia areata during the first half of 2023, following a positive read-out from the first of two phase III trials of the oral Janus kinase 1/2 inhibitor. The molecule hit the primary endpoint of the placebo-controlled Thrive-AA1 study, which was defined as the percentage of patients achieving a SALT (Severity of Alopecia Assessment Tool) score of 20 or less after 24 weeks of therapy.
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
